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Completed

NCT Number: NCT04704037

Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lion's Gate Hosital, North Vancouver, British Columbia, Canada

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About this study

Goal: To determine if a clinical practice guideline implementation tool, designed to support proactive management of mental health complications, can improve clinical outcomes from mild traumatic brain injury (mTBI).

Background: Up to 1 in 4 people who sustain an mTBI develop depression or an anxiety disorder within the first 3 months. Mental health problems triple the risk of long-term disability after mTBI. However, mental health disorders after mTBI are under-detected and under-treated. Canadian clinical practice guidelines for mTBI developed by the Ontario Neurotrauma Foundation (ONF) recommend that family physicians proactively screen and initiate treatment for mental health disorders.

Aims: To evaluate the effectiveness of an implementation intervention designed to facilitate timely detection and treatment of mental health complications in primary care.

Approach: Triple-blinded (treatment provider, patient, assessor) cluster randomized controlled trial with two arms. The intervention involves collecting screening test results from patients and a complex intervention with two components: sharing the screening test results in an actionable format with their family physician and activating patients for the clinical encounter with the family physician by sharing education materials about mental health problems and treatment options after mTBI. The comparison group is usual care.

Hypotheses: The researchers hypothesize that the guideline implementation tool will be associated with lower rates of mental health complications at 26 weeks post-injury, compared to usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-69 years old,
  • presentation to emergency department within 72 hours of injury,
  • probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria,
  • fluent in English,
  • primary residence in British Columbia,
  • designate a specific family physician or walk-in clinic where they plan to seek follow-up care

Exclusion criteria

  • Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
  • Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)

Treatment and study plan

Guideline implementation tool

Other

Family physicians will receive a tailored letter with their patient's mental health screening test results and associated mental health treatment recommendations from the Ontario Neurotrauma Foundation guidelines, as well as a list of mental health treatment resources. In addition, the patient will receive a written information package about mental health problems after mTBI and treatment options to discuss with their family physician.

Generic information about concussion management

Other

Family physicians will receive a generic letter drawing their attention to Canadian clinical practice guidelines for mild Traumatic Brain Injury (developed by the Ontario Neurotrauma Foundation). Patients will receive instructions about how to access generic education materials about mTBI (from concussion.vch.ca/), which they should have received anyway as part of usual care.

Primary outcomes

  1. MINI version 7.0.2 for DSM-5

    Time frame: 26 weeks post injury

    Structured diagnostic interview

Secondary outcomes

  1. Rivermead Postconcussion Symptom Questionnaire

    Time frame: 2, 12, 26 weeks post injury

    Standardized questionnaire

  2. World Health Organization Disability Assessment Schedule 2.0 12-item version

    Time frame: 12 and 26 week post injury

    Standardized interview

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: M4

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jan 11, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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